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| Study Name (Clinical trials identifier) | Study Population | Treatment Arms and Dosages | Survival Results |
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CheckMate 037
NCT01721746 | Advanced melanoma (Stage IIIc and IV) who have progressed on Ipilimumab and BRAF therapy | Arm 1: Nivolumab 3 mg/kg every 2 weeks treated until progression.
Arm 2: Investigator choice, which included dacarbazine 1000 mg/m2 every 3 weeks or carboplatin area under curve 6 plus paclitaxel 175 mg/m2 (Comparison) | OS
Arm 1: 16 months
Arm 2: 14 months
HR 0.95 (CI 0.73-1.24)
PFS
Arm 1: 3.1 months
Arm 2: 3.7 months
HR 1.0 (CI 0.78-1.436) |
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CheckMate 066
NCT01721772 | Advanced melanoma
(stage IIIc and IV) untreated without BRAF Mutation | Arm 1: Nivolumab 3 mg/kg every 2 weeks treated until progression.
Arm 2: Investigator choice, which included dacarbazine 1000 mg/m2 every 3 weeks or carboplatin area under curve 6 plus paclitaxel 175 mg/m2 (Comparison) | OS at 1 year
Arm 1: 72.9% (CI 65.5-78.9)
Arm 2: 42.1% (CI 33-50.9)
PFS
Arm 1: 5.1 months
Arm 2: 2.2 months
HR 0.43 (CI 0.34-0.56)
p<0.001 |
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CheckMate 067
NCT01844505 | Untreated stage III (unresectable) or Stage IV melanoma, With known BRAF V600 Mutation status, And with ECOG of 0 or 1 | Arm 1: Nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks for four doses followed by nivolumab 3 mg/kg every 2 weeks + placebo
Arm 2: Nivolumab 3 mg/kg every 2 weeks + Placebo
Arm 3: Ipilimumab 3 mg/kg every 3 weeks + placebo (Comparison) | OS at 3 years
Arm 1: 58 %
Arm 2: 52 %
Arm 3: 34%
PFS
Arm 1: 11.5 months
HR 0.43 (CI 0.35-0.52)
Arm 2: 6.9 months
Arm 3: 2.9 months
Arm 2 vs 3 HR 0.55 (CI 0.64-0.96) |
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CheckMate 069
NCT01927419 | Untreated stage III (unresectable) or stage IV melanoma, with BRAF wild type, ECOG of 0 or 1 | Arm 1: Nivolumab 1 mg/kg plus ipilimumab 3 mg/kg every 3 weeks for four doses followed by nivolumab 3 mg/kg every 2 weeks plus placebo
Arm 2: Ipilimumab 3 mg/kg every 3 week (Comparison) | OS 2-year follow-up data
Arm 1: 63·8% (CI 53·3–72·6)
Arm 2: 53·6% (CI 38·1–66·8)
HR 0·74, 95% (CI 0·43–1·26)
p=0·26
PFS at 2 years
Arm 1: Not reached
Arm 2: 3 months
HR 0.36 (CI 0.22-0.56) p <0.0001 |
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KEYNOTE 006
NCT01866319 | Unresectable Stage III Or IV advanced Melanoma (excluding Ocular melanoma) and up to one previous systemic chemotherapy (excluding anti CTLA- 4, PD-1 or PD-L1) | Arm 1: Pembrolizumab 10 mg/kg every 2 weeks
Arm 2: Pembrolizumab 10 mg /kg every 3 weeks
Arm 3: IV ipilimumab 3 mg/kg every 3 weeks (Comparison) | OS
Arm 1: NR (22.1-NR) HR
0.68 (0.53-0.87)
p<0.0009
Arm 2: NR (23.5-NR) HR
0.68 (053-0.86)
p <0.0008
Arm 3: 16 months (13.5-22)
PFS
Arm 1: 5.6 months HR 0.61 (0.5-075)
Arm 2: 4.1 months HR 0.61 (0.5-0.75)
Arm 3: 2.8 months HR NA
p<0.0001 |
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KEYNOTE 002
NCT0170428 | Unresectable stage III or stage IV melanoma, Confirmed Disease progression on previous BRAF, MEK or CTLA-4 inhibitor therapy. ECOG 0 or 1 | Arm 1: 180: Pembrolizumab 2 mg/kg
Arm 2: 181: Pembrolizumab 10 mg/kg iv every 3 Weeks
Arm 3: Investigator choice chemotherapy (paclitaxel plus carboplatin, paclitaxel, carboplatin, dacarbazine) (Comparison) | OS: NA
PFS at 6 months
Arm 1: 34% HR 0.57 (0.45-0.73) p<0.0001
Arm 2: 38% HR 0.5 (0.39-0.64) p <0.0001
Arm 3: 16% in comparison to above arms |
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